MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-302
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding infection and loosening involving a triathlon femoral component was reported.The event of infection was not confirmed.Loosening was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event date: (b)(6) 2021 (opened 06/17/2021) event description: sales rep was informed by doctor that there is a removal surgery plan on 28th june due to infected implant.Implants involved: triathlon materials reviewed: 06/10/2021: stryker pi report.Undated/unlabeled: implant sheet.Triathlon x3 size #2 cs poly 11mm (also lists a 9mm cs poly), size #3 cr femur, #2 primary tibia, symmetric patella 27mm, simplex p antibiotic.Undated: right ap/lateral knee x-rays.Gross loosening of tibia and femur.Tibia with catastrophic failure and proximal tibial fracture.Confirmation: a revision surgery and infection cannot be confirmed.Catastrophic failure and collapse of a triathlon implant construct femur and tibia can be confirmed.Root cause: a root cause cannot be ascribed without additional medical records.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  complaint history review: there have been no other similar events for the lot referenced.There has been one other similar events for the sterile lot referenced.The pi relates to infection.Conclusion: the medical review indicated: a revision surgery and infection cannot be confirmed.Catastrophic failure and collapse of a triathlon implant construct femur and tibia can be confirmed.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.  additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.   no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Catalog numbers and lot codes of other devices listed in this report: 5531g209 x3 triathlon cs insert #2 9mm, lot lje427.5550-g-278 triathlon symmetric x3 patella, lot: he17.61969001 simplex abc ce mark 1 pck, lot: bea011.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Sale rep was informed by doctor that there is a removal surgery plan on 28th june due to infected implant.Update as per med review dated 19 september 2021: undated: right ap/lateral knee x-rays.Gross loosening of tibia and femur.Tibia with catastrophic failure and proximal tibial fracture.Confirmation: a revision surgery and infection cannot be confirmed.Catastrophic failure and collapse of a triathlon implant construct femur and tibia can be confirmed.

• Brand Name: TRIATHLON CR FEM COMP #3 R-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12632830
• Report Number: 0002249697-2021-01705
• Device Sequence Number: 4290691
• Product Code: MBH
• UDI-Device Identifier: 07613327040265
• UDI-Public: 07613327040265
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 5510-F-302
• Device Catalogue Number: 5510F302
• Device Lot Number: HRR3T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention